CN105377169B - 用于神经调制的装置和方法 - Google Patents
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Abstract
本发明公开了用于神经和组织调制的***。示例性***可包括血管内神经调制***，其具有导管杆、可扩张笼状物和一个或多个附接至可扩张笼状物的电极组件。一个或多个电极组件可使用一个或多个覆盖物或涂层附接至可扩张笼状物。
Description
相关申请的交叉引用
根据《美国法典》35卷§119，本申请要求于2013年7月11日提交的美国临时申请序号第61/845,289号的优先权，其全部内容通过引用合并在此。
技术领域
本发明大体涉及用于神经调制和/或消融的经皮和血管内装置。
背景技术
某些治疗涉及，并且在一些情况下要求暂时或永久中断或改变选择的神经功能。一种示范治疗是肾神经消融，其可用来治疗与充血性心力衰竭有关的病况。肾脏对充血性心力衰竭产生交感神经响应，除了其他影响之外，交感神经响应提高了水和/或钠不期望的滞留。对一些延伸到肾脏的神经进行消融可降低或消除这种交感神经功能，这可促进相关联的不期望症状的相应减轻。
许多身体组织，诸如神经，包括肾神经、脑组织、心脏组织和其他身体器官的组织，紧密靠近血管和/或其他体腔。这种靠近使得能够通过血管壁经皮或在血管内进入组织。在一些情况下，可能期望使用射频(RF)电极来消融血管周围神经。在其他情况下，血管周围神经可通过其他技术消融，包括施加热、超声、激光、微波、和/或其他相关能量源至血管壁的手术。
提供包括但不限于肾神经调制***及其使用和制造方法的装置和方法是有利的，其提高和/或以其他方式增强了电能在患者体内预期治疗区内传送的有效性。
发明内容
本发明涉及用于执行神经消融的血管内神经调制***。
于是，一种示例性实施方式包括血管内神经调制***，其包括具有近端、远端和在其间延伸的腔的细长外杆，以及具有近端和远端的细长内杆。该***可进一步包括具有近端和远端的可扩张笼状物。可扩张笼状物的近端可附接至细长外杆的远端附近。电极组件可附接至可扩张笼状物的外表面，并且外覆盖物可设置在可扩张笼状物的外表面及电子元件的至少一部分上。在一些实施方式中，笼状物的远端可附接至或毗连内管的远端，使得在扩张形态下，可扩张笼状物的远端和可扩张笼状物的近端可具有逐渐减小的截面面积。在其他实施方式中，在扩张形态下，可扩张笼状物的远端的截面面积可大于可扩张笼状物的近端。
一些实施方式的上述总结并不旨在描述各公开的实施方式或者本发明的每个实施方式。更特别地，后面的附图和具体实施方式举例说明了这些实施方式。
附图说明
连同附图，考虑以下各种实施方式的具体说明可更加完整地了解本发明，其中：
图1是原位肾神经调制***的示意图。
图2A-2D示出了示例性肾神经调制装置的远侧部分。
图3示出了图2A-2D中包括促动机构的示例性肾神经调制装置。
图4示出了一些示例性电极组件。
图5示出了另一示例性肾神经调制装置的远侧部分。
图6A-6C示出了另一示例性肾神经调制装置的远侧部分。
图7示出了图6A-6C中包括促动机构的示例性肾神经调制装置。
图8示出了另一示例性肾神经调制装置的远侧部分。
虽然本发明可修改成各种改型和替代形式，但其细节已经由附图中的示例示出，并会详细描述。然而，应当认识到，本发明并不限于描述的特定实施方式。相反，本发明覆盖了所有落入在本发明实质和范围内的改型，等同形式，以及替代形式。
具体实施方式
以下说明应当参照附图来阅读，其中在全部附图中，相同的附图标记表示相同的元件。附图，不必成比例，并不旨在限制请求保护的本发明的范围。具体实施方式和附图说明了请求保护的本发明的示范实施方式。
本文中使用或另外包含的所有数值应当认为是由术语“大约”修饰。由端点限定的数值范围的公开或引述包括在那个范围内的所有数值(例如，1至5包括1、1.5、2、2.75、3、3.80、4和5)。
如本说明书和所附权利要求中所使用的，单数不定冠词“一”和定冠词“该”应当认为包括或另外覆盖单数和复数指代，除非文中清楚地表明并非如此。换句话说，这些冠词应用于一个或多个指代。如本说明书和所附权利要求中所使用的，术语“或者”应当认为是意味着“和/或”，除非文中清楚地表明并未如此。
本说明书中提及“一实施方式”，“一些实施方式”，“其他实施方式”等表明描述的实施方式可包括特定的特征，结构和/或特性，但不必每个实施方式都包括该特定的特征，结构和/或特性。此外，这种短语不必指代同一实施方式。而且，当在一实施方式中描述了特定的特征，结构和/或特性时，无论是否明确说明，本领域技术人员应当认识到这种特征，结构和/或特性也可用在其他的实施方式中，除非清楚地表明相反。
某些治疗需要暂时或永久中断或者改变选择的神经功能。一个示范治疗是肾神经消融，其有时用来治疗与高血压、充血性心力衰竭、糖尿病有关的状况，或者其他受高血压或盐滞留影响的状况。肾脏对充血性心力衰竭产生交感神经响应，除了其他影响之外，交感神经响应提高了水和/或钠不期望的滞留。对一些延伸到肾脏的神经进行消融可减少或消除这种交感神经功能，这可促进相关联的不期望的症状相应减轻。
本文公开了许多通过血管壁进行肾神经调制的情况下的装置和方法。然而，其他实施方式中的装置和方法可用在其他情况下，例如除了期望进行神经调制和/或消融之外的应用。可以预期，装置和方法可用于期望进行神经调制和/或其他组织调制的其他治疗位置和/或应用中，包括加热、激活、阻断、破坏或消融，诸如但不限于：血管、膀胱或经由套针和插管进入的其他组织中。例如，本文描述的装置和方法可适用于增生组织消融、心脏消融、肺静脉隔离、肿瘤消融、良性***增生治疗、神经刺激或阻断或消融、肌肉活动调制、组织的过高热或其他加热等。公开的方法和设备可适用于任何相关的医疗过程，包括人类和非人类对象。术语调制是指消融和可改变受影响的神经和其他组织的功能的其他技术。在一些实施方式中，根据需要，单个消融装置可用来顺序地或同时地执行多个消融。
图1是原位示例性肾神经调制***的示意图。肾神经调制***10可包括一个或多个用来提供电能至肾神经调制装置的导电元件16。示例性肾神经调制装置可包括可选择地设置在递送鞘套或引导导管14内的血管内导管或神经调制装置12。递送鞘套14适合于在血管内导管12的径向扩张远侧部分(未示出)处于非扩张形态时可滑动地包住血管内导管12，如以下更详细地讨论的。各导电元件16的远端附装至一个或多个位于血管内导管12的远端或远端附近的位置处的电极。各导电元件16的近端可连接至功率控制单元18，其供给用来激活一个或多个电极的电能。功率控制单元18通常位于患者体外。电极能够在经由控制单元18适当激活时调制或消融组织。
在以下披露中，术语电极可认为等同于能够消融邻近的组织的元件。“邻近的组织”的披露旨在覆盖充分靠近电极以进行消融的任何组织，并且有关的位置和距离旨在根据应用和/或其他因素而变化。
功率控制单元18可包括监测元件以监测诸如功率、温度、电压、脉冲振幅、阻抗和/或形状的参数，和/或其他合适的参数。功率控制单元18还可包括沿肾神经调制装置安装的传感器以及用于执行期望手术的合适的控制装置，或者以其他方式与沿肾神经调制装置安装的传感器以及用于执行期望手术的合适的控制装置一起使用。在一些实施方式中，控制单元18可控制射频(RF)电极。电极可配置成以大约460kHz的频率工作。然而，可使用射频范围内任何期望的频率，例如，从450到500kHz。另外，按照要求，可使用其他类型的消融装置，包括但不限于，涉及电阻加热、超声、微波和激光技术的装置。功率控制单元18可供给不同形式的能量至这些装置。
图2A-2D和图3示出了示例性肾神经调制装置100的远侧部分，其具有涂覆有涂层的笼状结构。首先参照图2A，肾神经调制***100可包括具有细长外杆102和细长内杆104的导管杆。细长外杆102可从远端区域108向近侧延伸至配置成留在患者体外的近端。细长内杆104可滑动地设置在细长外杆102的腔106内。细长内杆104可从远端区域110向近侧延伸至配置成留在患者体外的近端。尽管未示出，细长内和/或外杆104、102的近端可包括附装其上用于连接其他治疗装置或提供便利其他治疗的端口的毂(hub)。可以预期，细长内和/或外杆104、102的刚度可改变以形成用于各种血管直径和血管树内各种位置的调制装置100。
在一些情况下，细长内和/或外杆104、102可具有细长管状结构，并可包括一个或多个延伸穿过其的腔。例如，在示出的实施方式中，细长外杆102可包括可滑动地容纳细长内杆104的腔106。管状内杆104可包括腔(未明确示出)，该腔具有可滑动地设置在其中的导丝112。在一些情况下，在没有导丝腔时，调制装置100可具有固定的丝线远端。这些仅是示例。在一些实施方式中，细长内和/或外杆104、102可包括一个或多个辅助腔。在一些情况下，细长内和/或外杆104、102可包括用于灌注流体(诸如盐水或用于可视化的染料)或为了其他目的(诸如引入医疗器械等)的单独腔(未示出)。除了冷却体腔之外，流体可促进消融过程中调制装置100的冷却。而且，腔可以以本领域已知的任何方式配置。例如，腔可沿细长内和/或外杆104、102的整个长度延伸(诸如在丝上(over-the-wire)导管中)或者可仅沿细长内和/或外杆104、102的远侧部分延伸(诸如在单个操作者交换(single operatorexchange，SOE)导管中)。这些示例并非旨在限制，而是一些可能的构造的示例。虽然未明确示出，调制装置100可进一步包括温度传感器/丝线、灌注腔、不透射线的标识带、固定的导丝末端、导丝腔和/或其他组件以便利装置100在血管内的使用和推进。
而且，细长内杆和/或外杆104、102可具有相对较长、薄、柔性的管状构造。在一些情况下，细长内和/或外杆104、102可具有大体圆形的截面，然而，也可以预期其他合适的构造，诸如但不限于，矩形、椭圆形、不规则形等。另外，细长内和/或外杆104、102可具有适合于容纳在预期的血管(诸如肾动脉)中的截面构造。例如，细长内杆和/或外杆104、102可具有一定大小并配置成容纳穿过血管内路径的通道，该通道从例如股动脉、肱动脉或桡动脉上的经皮进入部位通向例如在肾动脉内的目标治疗部位。
调制装置100可进一步包括具有近端116和远端118的可扩张笼状物114。在扩张形式下，笼状物114可具有逐渐减小的近端116和逐渐减小的远端118，以及增大的中心区，尽管这不是必需的。在一些实施方式中，可扩张笼状物114可由大体管状部件激光切割得到以形成期望的图案。虽然可扩张笼状物114示出为具有开放孔、大体支架似的结构，可以预期，笼状物114可形成具有许多不同构造中的任意一种。例如，在一些情况下，笼状物114可由许多大体纵向延伸的尖齿(tines)构成或者可由编织、编结、捆扎等的一个或多个丝状体构成。这些仅是示例。可以预期，使用可扩张笼状物114可消除对膨胀腔的需要，这样减小了调制***100的整个轮廓。
可以预期，按照要求，可扩张笼状物114可由许多不同的材料制成，诸如但不限于，金属、金属合金、形状记忆合金和/或聚合物，使笼状物114能够在定位在体内时扩张形状。例如，可扩张笼状物114可由合金制成，诸如但不限于，镍钛诺或根据构造选择的材料，笼状物114可自扩张或者可需要一促动机构，如以下更详细地讨论的。在一些实施方式中，纤维可用来制造可扩张笼状物114，其可以是有芯纤维，例如，具有由镍钛诺制成的外壳并具有铂芯。还可以预期，可扩张笼状物114可由聚合物制成，包括但不限于，聚醚醚酮(PEEK)、尼龙、聚对苯二甲酸乙二醇酯(PET)、聚酰亚胺、聚醚嵌段酰胺等。
笼状物114的近端116可固定至或毗连细长外杆102的远端区域108。笼状物114的远端118可固定至或毗连细长内杆104的远端区域110。在一些情况下，笼状物114的远端118可直接固定至细长内杆104。在其他情况下，笼状物114的远端118可固定至安装元件120。安装元件120可滑动地设置在细长内杆104上或者可固定地固定至细长内杆104。如上所述，在一些情况下，笼状物114可自扩张。可以预期，自扩张的笼状物114可在外力作用于笼状物114上时保持处于压缩(或者塌缩)状态。然后当外力释放时，笼状物114可扩张。在这种情况下，笼状物114可形成处于扩张状态(如图2A所示)，然后压缩以适合装在递送鞘套中。到达目标位置时，递送鞘套可缩回以使可扩张笼状物114展开。可以预期，在一些情况下，笼状物可自扩张，而不需要俘获鞘套，因为引导鞘套能够将笼状物引入到血管中，并且如果覆盖材料使得笼状物114足够防止损伤，那么笼状物能够在扩张的同时引入到动脉中。
在其他实施方式中，***100可包括促动机构，例如，拉线132(见图3)，其可用来操控或促动可扩张笼状物114在塌缩和扩张形态之间转换。在一实施方式中，拉线132可附装至笼状物114的近端116或远端118，使得拉线132的推-拉促动可操控可扩张笼状物114，从而促动可扩张笼状物114在塌缩和扩张形态之间转换。在一些情况下，可向近侧拉动拉线132以拉动可扩张笼状物114，使可扩张笼状物114移至扩张形态。另外，可向远侧推动拉线132以使可扩张笼状物114移至塌缩形态。或者，可向远侧推动拉线132，这可允许可扩张笼状物114移至扩张状态。在这种情况下，可向近侧拉动拉线132，这可允许可扩张笼状物114移至塌缩状态。
图2B示出图2A中包括附加组件的调制***100。调制***100可进一步包括设置在可扩张笼状物114内表面上的内覆盖物或涂层122。在一些情况下，内覆盖物122可使用本领域中通常已知的方法附接至笼状物114。内覆盖物122可由弹性体材料制成，诸如但不限于：聚氨酯、硅酮等。弹性体材料可有助于使笼状物114在使用后闭合至未扩张的形态。然而，在一些情况下，诸如聚氨酯的弹性体可能由于消融产生的热而失效。为了防止弹性体失效，弹性体可使用较高温度的材料(例如，使用二氧化硅掺杂到弹性体中以提高其熔点)隔离在电极周围，也可使用较高温度的尿烷(例如，浸渍涂覆而不是挤压的芳香烃)。或者，覆盖物材料可以是较低可伸展性的材料，例如，四氟乙烯(Tfe)、聚对苯二甲酸乙二醇酯(PET)、或纤维织物(例如，聚酯或聚合物涂覆的纤维织物)，其受消融温度的影响更小。可以预期，内覆盖物122可从笼状物114的近端116延伸至远端118。然而，这不是必需的。可以预期，内覆盖物122可延伸越过笼状物114期望的任何长度或部分长度，或者内覆盖物122甚至可以不存在。
调制***100可进一步包括一个或多个定位在可扩张笼状物114和/或内覆盖物122的表面上以传送射频能量至期望的治疗区域的电极组件124a、124b。在一些情况下，一个或多个电极组件124a、124b可定位在外覆盖物130的表面上(见图2C)。可与本文公开的实施方式一起使用的示范电极组件在名为“Spiral bipolar electrode renal denervationballoon”的美国专利申请序号第61/856,523号(代理案号1001.3432100)中公开，其全部内容通过引用合并在此。各电极组件124a、124b可构建为具有多层的柔性电路。这种层可以是连续或非连续的，即，由离散部分组成。绝缘的基层125a、125b可提供电极组件124a、124b的基座。基层125a、125b可由诸如聚酰亚胺的柔性聚合物构建而成，尽管也可以考虑其他的材料。然而，本文公开的调制***并不旨在局限于仅使用柔性电路来传送治疗能量至治疗区域。可以预期，能量传送装置可以是期望的任何类型。由多个离散迹线组成的导电层可层叠在基层125a、125b的顶部。导电层可以是，例如，电沉积铜的层。也可以考虑其他的材料。绝缘层可离散地或连续地层叠在导电层的顶部，使得导电层可流体密封在基层125a、125b与绝缘层之间。像基层125a、125b一样，绝缘层可由诸如聚酰亚胺的柔性聚合物构建而成，尽管也可以考虑其他的材料。在其他实施方式中，绝缘层可以是完整的或部分的聚合物涂层，诸如聚四氟乙烯或硅酮。也可以考虑其他材料。
电极组件124a、124b可包括远侧电极极板129a、129b。在这个区域，基层125a、125b可形成矩形形状。这并非旨在限制。也可以考虑其他形状。虽然未明确示出，电极组件124a、124b可包括多个开口以提供更多的柔性，并且组件的极板和其他部分可包括圆的或弯曲的角、过渡区和其他部分。在一些情况下，开口和圆的/弯曲的特征可提高组件抵抗与可扩张装置分层的能力，在一些情况下，当可扩张装置反复扩张和塌缩时(其也是可扩张装置从保护鞘套中展开和退回到保护鞘套中所必需的)，诸如在手术过程中治疗多个部位时可能需要的，分层可能出现。可以预期，在一些实施方式中，可能不需要基层125a、125b。例如，电子元件、电极和热敏电阻可安装在笼状物114上或者内覆盖物122或外覆盖物130上(见图2C和2D)，并且导电迹线可以是细金属丝，或者导电迹线可使用例如微笔(Micropen)技术描绘在内覆盖物122或外覆盖物130内。
远侧电极极板129a、129b可包括多个层叠在基层125a、125b顶部的离散迹线128a、128b。这些迹线可包括接地迹线、有源电极迹线和传感器迹线(未明确示出)以电连接电极、元件和/或功率控制单元。接地迹线可包括从传感器接地极板横向偏移的细长电极支撑物。传感器接地极板可电连结至接地迹线的细长支撑物，并可位于所述远侧电极极板的中心。桥接器可连接传感器接地极板的最远侧部分至接地迹线的细长电极支撑物的远侧部分。随着桥接器行进至传感器接地极板，桥接器的宽度可逐渐减小。在一些实施方式中，桥接器可具有相对一致且细的宽度，使得桥接器能够具有期望的柔性量。细长电极支撑物可在它的近端宽度逐渐减小，然而，这不是必需的。在一些实施方式中，细长电极支撑物可在它的近侧部分突然转变成细得多的迹线，使其能够具有期望的柔性量。也可使迹线的形状和位置最优化以提供电极组件124a、124b整体的尺寸稳定性，以防止展开和使用的过程中扭曲。接地迹线和有源电极迹线可具有类似的构造。有源电极迹线也可包括细长电极支撑物。
接地电极迹线和有源电极迹线可包括多个电极126a、126b。可为各电极迹线设置三个电极126a、126b，然而，可使用更多或更少的电极。另外，各电极126a、126b可具有倒圆角以降低被其他装置和/或组织挂住的可能。尽管已在双极电极组件的情况下描述了电极126a、126b和相关联的迹线的以上说明，本领域技术人员应当意识到，相同的电极组件也可在单极模式下起作用。例如，作为一个非限制性示例，与有源电极迹线相关联的电极可用作单极电极，在这些电极通电的过程中，接地迹线断开。
在一些实施方式中，电极126a、126b可以是从导电层起大约0.038mm厚的镀金极板，并且电极可在绝缘层125a、125b上突出大约0.025mm。在不限制使用其他此类合适材料的情况下，金可以是良好的电极材料，因为它非常生物相容性、不透射线并且导电且导热。在其他实施方式中，导电层的电极厚度可以在大约0.030mm到大约0.051mm的范围内。在这种厚度下，与例如铜的导电层相比，电极126a、126b的相对刚度可能是高的。由此，与使用单个电极相反，使用多个电极可提高柔性。在其他实施方式中，电极可小到大约0.5mm乘以大约0.2mm或者电极126a、126b可大到大约2.2mm乘以大约0.6mm。
传感器迹线可位于远侧电极极板129a、129b的中心，并可包括面向传感器接地极板的传感器电源极板。这些极板可连接至温度传感器127a、127b的电源极和接地极，诸如热电偶(例如，T型构造：铜/康铜)或热敏电阻。温度传感器127a、127b可在近侧连接至传感器电源极板，并可在远侧连接至传感器接地极板。为了帮助降低整体厚度，温度传感器127a、127b可定位在基层125a、126b中的开口内。
从远侧电极极板129a、129b开始，结合的基层125a、125b，导电层和绝缘层的横向宽度可减小至中间辫131a、131b。这里，导电层可形成包括中间接地线、中间有源电极线和中间传感器线，其分别是远侧电极极板129a、129b的接地迹线、有源电极迹线和传感器迹线扩及同空间的迹线。
从中间辫131a、131b开始，结合的基层125a、125b，导电层204和绝缘层206的横向宽度可增加以形成近侧电极极板133a、133b。近侧电极极板133a、133b可类似于远侧电极极板129a、129b构建而成，具有基本相同的电极几何形状和温度传感器布局，尽管可存在各种差异。然而，如所示的，近侧电极极板133a、133b可关于沿中间接地线延伸的中心轴线从远侧电极极板129a、129b横向偏移。中间有源电极线和中间传感器线可在各自平行于中心轴线的轴线上与近侧电极极板133a、133b横向扩及同空间。
从近侧电极极板133a、133b开始，结合的基层125a、125b，导电层和绝缘层的横向宽度可减小以形成近侧辫135a、135b。近侧辫135a、135b可包括近侧接地线、近侧有源电极线和近侧传感器线，以及中间有源电极线和中间传感器线。近侧辫135a、135b可包括连接器(未示出)以使近侧辫135a、135b能够连结至一个或多个子线束和/或连接器，并最终连接至功率控制单元。这些线中的每一个可沿各自平行于中心轴线的轴线延伸。
如所示的，电极组件124a、124b可具有远侧电极极板129a、129b和近侧电极极板133a、133b关于中心轴线对称的布局。而且，两个电极极板的接地电极可连同中间和近侧接地线一起沿中心轴线大致对齐。已发现，这种布局可表现出某些优势。例如，由于基本共享同一接地迹线，近侧辫的宽度可以仅是中间辫131a、131b宽度的大约一点五倍，而不是各电极极板具有独立接地线的情况下的大约两倍宽。这样，近侧辫135a、135b可以比两个中间辫131a、131b更窄。
而且，布局电极极板以共享接地迹线可允许控制哪些电极将相互作用。各种电极极板可使用固态继电器并用激发时间范围在大约100μs到大约200ms或者大约10μs到大约50ms的复用激发和控制。实际上，电极极板可看上去是同时激发的，然而，通过以微爆发(micro burst)迅速激发电极可防止不同电极组件124a、124b的相邻电极极板之间的杂散电流。这可执行成使得不同电极极板组件124a、124b的相邻电极极板相互异相激发。这样，电极组件的电极极板布局可允许短暂的治疗时间-大约10分钟或者更少的总电极激发时间，就大约30秒的示范实施方式而言，具有短至大约10秒的近似治疗时间。短治疗时间的一些益处可包括在神经组织遭受能量治疗时使造成的治疗后疼痛最小，缩短血管闭塞时间、减少闭塞副作用，以及由于相对较少的热输入至腔组织通过血液灌注可快速冷却旁系组织。
现在参照图4，示出了具有柔性电路202、204和206的柔性电路板200。各柔性电路202、204、206可包括电导线208，其在近侧电触点210和远侧电触点212之间延伸。导线208可由柔性聚合物衬底214支撑。然而，这不是必需的。可以预期，导线208、近侧电触点210和/或远侧电触点212可直接固定至本文描述的可扩张笼状物或框架中的任意一个或者固定至本文描述的覆盖物或涂层中的任意一个。在一些情况下，可在电路的电子元件周围和/或之间切割衬底214以固定电路202、204、206至期望的结构。电极212可定位在调制***的远端附近，同时导线208可沿装置向近侧延伸，使得近侧电触点210可电连接至功率控制单元，诸如图1中示出的功率控制单元18。一个或多个柔性电路202、204和206可固定至调制装置。可以预期，根据期望的治疗区域和装置大小，可存在任何期望数量的柔性电路。在一些情况下，各柔性电路202、204、206的电极212可选择地设置电极的群组或子阵列来治疗目标组织的相关部分或区域。替代子阵列可设置在不同柔性电路的电极之间，可由处理器的可编程逻辑限定，和/或可包括多种替代电极电路结构中的任意一种，子阵列通常用来复用或治疗具有多个不同的穿过组织的电能路径的目标组织区域。
仍参照图4，在阵列或子阵列的选定电极之间复用可通过有选择地对电极对供电实现，由于子阵列的目标组织区域设置在电极对的电极之间，所以能量经过其。例如，可对选自柔性电路202的电极1、2、3、4、5和6中的电极对(选定的电极可选择地定位成彼此相对的)供电，然后关闭，然后对另一对供电，诸如此类。激发次序可以是1和4，然后2和5，然后3和6。电极对的电极之间的双极电位可引起大体相同的组织区域中的电流路径，因为消散到组织中的能量可选择地保持大致恒定。这提供了大约Vi相对于各电极表面的热和/或损耗的占空比。柔性电路204和206四个电极的构造可以以类似方式使用，具有50％的占空比。在患者皮肤上使用较大的接地极板，单极能量也可适用，占空比相对于双极能量可选择地减少一半。
再次参照图2B，可以预期，基于调制装置100的大小和/或期望的治疗区域，调制***100可包括任何期望数量的电极组件124a、124b。例如，调制***可包括一个、两个、三个、四个、五个或更多的电极组件。进一步可以预期，电极组件124a、124b可沿可扩张笼状物114的周长(circumference)和/或长度错开，使得定位在调制装置上的电极组件124a、124b的数量可达到最大。
图2C示出了图2B中包括附加元件的调制***100。调制***100可进一步包括设置在可扩张笼状物114的外表面和内覆盖物122(当其存在时)上的外覆盖物或涂层130。外覆盖物130可由弹性体材料制成，诸如但不限于：聚氨酯、硅铜等。弹性体材料可帮助笼状物114在使用后闭合至未扩张的形态。然而，在一些情况下，诸如聚氨酯的弹性体可能由于消融产生的热而失效。为了防止弹性体失效，弹性体可使用较高温度的材料(例如，使用二氧化硅，掺杂到弹性体中以提高其熔点)隔离在电极周围，或者也可使用较高温度的尿烷(例如，浸渍涂覆而不是挤压的芳香烃)。或者，覆盖物材料可以是较低可伸展性的材料，例如，四氟乙烯(Tfe)、聚对苯二甲酸乙二醇酯(PET)、或纤维织物(例如，聚酯或聚合物涂覆的纤维织物)，其受消融温度的影响更小。可以预期，外覆盖物130可从笼状物114的近端116延伸至远端118。然而，这不是必需的。可以预期，外覆盖物130可在笼状物114的期望的任何长度或部分长度上延伸，或者外覆盖物130甚至可以不存在。根据需要，内和外覆盖物122、130可由相同材料制成，或者可由不同材料制成。在一些实施方式中，内和外覆盖物122、130中的一个或两者可省略。
在一些情况下，外覆盖物130可使用本领域通常已知的方法附接至内覆盖物122和/或笼状物144。同时，内和外覆盖物122、130可包住电极组件124a、124b和相关电子器件的全部或部分。可以预期，与将柔性电路固定至传统的可膨胀球囊相比，内和外覆盖物122、130可将电极组件124a、124b更稳固地固定至可扩张笼状物114，因为内和外覆盖物122、130夹住电极组件124a、124b，并且更能经受得住共价粘合结合。可以预期，将电极组件124a、124b粘在至少笼状物114和外覆盖物130之间可改善电极至***的固定，因为这种布局可消除或减少不依赖于粘合剂的电极支撑点，从而将电极组件124a、124b固定至调制***。这可提高***100的安全性。
当外覆盖物130设置在电极126a、126b上时，电极可绝缘接触期望的治疗区域。在一些情况下，外覆盖物130可以不在电极组件124a、124b的电极126a、126b上延伸，如图2D所示。例如，在施加外覆盖物130之前，电极126a、126b可涂覆或覆盖有掩模材料。一旦形成外覆盖物130，可去除掩模材料以露出电极130。在一些情况下，外覆盖物130可设置在电极130上，随后去除，用诸如但不限于激光消融的方法。这可允许电极326直接接触血管壁。进一步可以预期，外覆盖物130可从电极126上去除，然后电极126独立地涂覆(例如使用聚对二甲苯)以绝缘接触期望的治疗区域。
在一些实施方式中，在笼状物114的近端116和远端118，内和/或外覆盖物122、130可包括多个孔或穴(未明确示出)以允许血液在笼状物114扩张时向***100下游灌注。优选隔离接触消融，以允许血液冷却动脉的内膜表面，使动脉内表面免受消融作用的影响。
图3示出了图2A-2D中包括示例性促动机构134以促动笼状物114在塌缩和扩张位置之间转换的调制***。促动机构134可包括手柄或握持部分136和触发部分138。触发部分138可连接至拉线132的近端。如上面讨论的，拉线132的远端可附装至或毗连笼状物的近端116或远端118。促动机构134可配置成使触发部分138的促动导致拉线132向近侧和/或向远侧促动，随后，导致笼状物114扩张或收缩。虽然促动机构134示出为包括手柄136和触发机构138，可以预期，拉线132能够以期望的任何方式促动，诸如但不限于，滑动机构、按钮等。
调制***100可以以本领域已知的任何方式前进通过血管。例如，***100可包括导丝腔，以允许***100沿先前定位的导丝前进。在一些实施方式中，调制***100可在引导鞘套(诸如图1中示出的鞘套14)内前进或部分前进。一旦调制***100的电极组件124a、124b放置在期望的治疗区域附近，可扩张笼状物114可扩张使电极126a、126b与血管壁形成接触。
可以预期，笼状物114的扩张可控制为使得电极可始终如一地与动脉壁接触。在一些情况下，可基于血管的尺寸和/或形状调节笼状物114的扩张直径和/或截面。例如，医师能够在较小的血管中部分扩张笼状物114，在较大的血管中完全扩张笼状物114。这可允许对整个患者治疗动脉直径(或截面面积)范围所需要的导管型号更少，并可允许对大约25％的患者仅需要一个导管，这里患者的左右肾动脉直径变化超过1mm，因为笼状物114可扩张从而改变了直径。进一步可以预期，可扩张笼状物可降低对动脉壁的创伤，因为笼状物114在提供更加完整的并置时会提供较低的并置力。
在一些实施方式中，笼状物114可设计成允许电极组件124a、124b相互独立地径向移动，允许血管直径沿血管长度变化时更好的电极126a、126b并置。例如，笼状物114的远端118可扩张成与笼状物114的近端116不同的截面。在这种情况下，笼状物114可扩张至不同程度以大体符合沿血管长度具有变化的直径的血管。在一些实施方式中，笼状物114的远端118的截面可小于或大于笼状物114的近端116。这可允许调制***100用于非周向血管以及逐渐减小的血管中，同时仍然提供良好的电极126a、126b接触。
虽然未明确示出，电极组件124a、124b可通过电导线128a、128b连接至单个控制单元或者连接至独立的控制单元(诸如图1中的控制单元18)。一旦调制***100前进至治疗区域，可供给能量至电极组件124a、124b。传送至电极组件124a、124b的电能的量可由预期的治疗以及***100的其他组件(诸如但不限于温度传感器127a、127b)提供的反馈决定。
一旦消融了特定的位置，可能期望在不同的纵向位置进一步执行消融过程。一旦重新纵向定位了调制***100，能量可再次传送至电极组件124a、124b。如有必要，在各纵向位置可转动调制***以在血管的周向周围执行消融。在期望的任何数量的纵向位置处，可重复这个过程。
当调制过程完成时，笼状物114可塌缩以从体内取出。可以预期，笼状物114和电极组件124a、124b可以以不出现“翼”的方式塌缩。这可降低取出***100所需的力。进一步可以预期，包住电极组件124a、124b和相关电子器件的全部或部分也可减少调制***100上的潜在“捕获”点，这也可降低取出***100所需的力。
图5示出了另一个示例性肾神经调制装置300的远侧部分，其具有覆盖有涂层的笼状结构。肾神经调制***300可包括具有近端和远端区域308的细长外杆302。细长外杆302可从远端区域308向近侧延伸至配置成留在患者体外的近端。调制装置300可进一步包括可滑动地设置在细长外杆302的腔306内的细长内杆304。细长内杆304可从远端区域310向近侧延伸至配置成留在患者体外的近端。细长内杆304可包括腔(未明确示出)，其具有可滑动地设置在腔内的导丝312。在一些情况下，调制装置300可具有固定的丝线远端，而没有导丝腔。尽管未示出，细长内杆和/或外杆304、302的近端可包括附装其上用于连接其他治疗装置或者提供便利其他治疗的端口的毂。可以预期，细长内和/或外杆304、302的刚度可改变以形成用于各种血管直径和血管树内各种位置的调制装置300。细长内和/或外杆304、302在形式和功能上可类似于上述细长内和/或外杆104、102。
调制装置300可进一步包括具有近端316和远端318的可扩张笼状物314。在一些实施方式中，可扩张笼状物314可由大体管状部件激光切割得到以构成期望的图形。虽然未明确示出，可扩张笼状物可具有开放孔、大体上类似于支架的结构。在其他情况下，可以预期，笼状物314可形成具有许多不同构造中的任何一种。例如，在一些情况下，笼状物314可由许多大体纵向延伸的尖齿(tines)制成或者可由编织、编结、捆扎等一个或多个丝状体制成。这些仅是示例。笼状物314在形式和功能上可类似于上述笼状物114。取决于构建选择的材料，笼状物314可自扩张或者可需要诸如上述促动机构134的促动机构。
笼状物314的近端316可固定至或毗连细长外杆302的远端区域308。笼状物314的远端318可固定至或毗连细长内杆304的远端区域310。在一些情况下，笼状物314的远端318可直接固定至细长内杆304。在其他情况下，笼状物314的远端318可固定至安装元件320。安装元件320可滑动地设置在细长内杆304上或者可固定地固定至细长内杆304。如上所述，在一些情况下，笼状物314可自扩张。可以预期，自扩张的笼状物314在外力作用于笼状物314上时可保持处于压缩(或者塌缩)状态。然后当外力释放时，笼状物314可扩张。在这种情况下，笼状物314可形成为处于扩张状态(如图5所示)，然后被压缩以适合装在递送或俘获鞘套中。到达目标位置时，递送鞘套可缩回以展开可扩张笼状物314。在一些情况下，血管接入导管可起到俘获鞘套的作用。
在其他实施方式中，***300可包括促动机构，诸如上述促动机构134，其可用来操控或促动可扩张笼状物314在塌缩和扩张形态之间转换。在一实施方式中，拉线可附接至笼状物314的近端316或远端318，使得拉线的推-拉促动可操控可扩张笼状物314，从而促动可扩张笼状物314在塌缩和扩张形态之间转换。在一些情况下，可向近侧拉动拉线以拉动可扩张笼状物314，使可扩张笼状物314移动至扩张形态。另外，可向远侧推动拉线以使可扩张笼状物314移至塌缩形态。或者，可向远侧推动拉线，这可允许可扩张笼状物314移至扩张状态。在这种情况下，可向近侧拉动拉线，这可允许可扩张笼状物314移至塌缩状态。
调制***300可进一步包括设置在可扩张笼状物314的内表面上的内覆盖物或涂层(未明确示出)。可以预期，内覆盖物可延伸笼状物314期望的任何长度或部分长度，或者内覆盖物甚至可以不存在。然而，这不是必需的。可以预期，在一些情况下，内覆盖物可从笼状物314的近端316延伸至远端318。
调制***300可进一步包括一个或多个定位在可扩张笼状物314和/或内覆盖物的外表面上用于传送射频能量至期望的治疗区域的电极组件(未明确示出)。电极组件在形式和功能上可类似于上述电极组件124a、124b。然而，本文公开的调制***并不旨在局限于仅使用柔性电路来传送治疗能量至治疗区域。可以预期，能量传送装置可以是任何期望的类型。电极组件上的电极326可通过一个或多个电导线328相互连接，连接至其他电子元件，和/或功率控制单元。根据需要，电极326可以以双极或单极模式操作。
可以预期，基于调制装置300的大小和/或期望的治疗区域，调制***300可根据需要包括任何数量的电极组件。例如，调制***可包括一个、两个、三个、四个、五个、或更多的电极组件。进一步可以预期，电极组件可关于可扩张笼状物314的周长和/或长度错开，使得定位在调制装置上的电极组件的数量可达到最大。
调制***300可进一步包括设置在可扩张笼状物314的外表面上和内覆盖物(当存在时)上方的外覆盖物或涂层330。外覆盖物330在形式和功能上可类似于上述外覆盖物130。可以预期，外覆盖物330可具有近端331和远端333。在一些情况下，覆盖物330的近端331可定位在笼状物314近端316的远侧。进一步可以预期，覆盖物330的远端333可定位在笼状物314远端318的近侧。这可允许血液在治疗过程中向调制***300的下游灌注。然而，可以预期，外覆盖物330的近端331或远端333中的一个或两者可延伸至框架314的近端316或远端318。可以预期，内覆盖物可具有与外覆盖物330相似的构造。根据需要，内和外覆盖物330可由相同材料制成，或者可由不同材料制成。在一些实施方式中，内和/或外覆盖物330中的一个或两者可省略。
在一些情况下，外覆盖物330可使用本领域通常已知的方法附接至内覆盖物和/或笼状物314。同时，内和外覆盖物330可包住电极组件和相关电子器件的全部或部分。可以预期，与将柔性电路固定至传统的可膨胀球囊相比，内和外覆盖物330可将电极组件更稳固地固定至可扩张笼状物314，因为内和外覆盖物330夹住电极组件，并且更能经受得住共价粘合结合。在一些情况下，外覆盖物330可以不在电极组件的电极326上延伸。例如，在施加外覆盖物330之前，电极326可涂覆或覆盖有掩模材料。一旦形成外覆盖物330，可去除掩模材料以露出电极330。在一些情况下，外覆盖物330可设置在电极330上，随后去除，用诸如但不限于激光消融之类的方法。这可允许电极326直接接触血管壁。在其他情况下，外覆盖物330可留在电极326上以允许绝缘的壁接触。进一步可以预期，外覆盖物330可从电极326上去除，且电极326被独立涂覆(例如使用聚对二甲苯)以绝缘接触期望的治疗区域。
图6A-6C和7示出了示例性肾神经调制装置400的远侧部分，其具有覆盖有涂层的笼状结构。首先参照图6A，肾神经调制***400可包括具有近端和远端区域408的细长外杆402。细长外杆402可从远端区域408向近侧延伸至配置成留在患者体外的近端。调制装置400可进一步包括细长内杆404，其具有可滑动地设置在细长外杆402的腔406内的防止损伤的末端420。细长内杆404可从远端区域410向近侧延伸至配置成留在患者体外的近端。尽管未示出，细长内和/或外杆404、402的近端可包括附装其上用于连接其他治疗装置或者提供端口以便利其他治疗的毂。可以预期，细长内和/或外杆404、402的刚度可改变以形成用于各种血管直径和血管树内各种位置的调制装置400。
在一些情况下，细长内和/或外杆404、402可具有细长管状结构，并可包括一个或多个延伸穿过其的腔。例如，在示出的实施方式中，细长外杆402可包括可滑动地容纳管状内杆404的腔406。管状内杆404可包括腔(未明确示出)，该腔可滑动地容纳导丝在其中。在一些情况下，在没有导丝腔时，调制装置400可具有固定的丝线远端。这些仅是示例。在一些实施方式中，细长内和/或外杆404、402可包括一个或多个辅助腔。在一些情况下，细长内和/或外杆404、402可包括用于灌注流体或用于其他目的(诸如引入医疗器械等)的单独腔(未示出)。除了冷却体腔之外，流体可促进消融过程中调制装置400的冷却。而且，腔可以以本领域已知的任何方式配置。例如，腔可沿细长内和/或外杆404、402的整个长度延伸(诸如在丝上(over-the-wire)导管中)或者可仅沿细长内和/或外杆404、402的远侧部分延伸(诸如在单个操作者交换(single operator exchange，SOE)导管中)。这些实例并非旨在限制，而是一些可能的构造的示例。虽然未明确示出，调制装置400可进一步包括温度传感器/丝线、灌注腔、不透射线的标识带、固定的导丝末端、导丝腔、和/或其他组件以便利装置400在血管内的使用和推进。
而且，细长内和/或外杆404、402可具有相对长、薄、柔性的管状构造。在一些情况下，细长内和/或外杆404、402可具有大体环形的截面，然而，也可以预期其他合适的构造，诸如但不限于，矩形、椭圆形、不规则形等。另外，细长内和/或外杆404、402可具有适合于容纳在预期的血管(诸如肾动脉)中的截面构造。例如，细长内和/或外杆404、402可具有一定大小并配置成提供穿过血管内路径的通道，该通道从例如股动脉、肱动脉或桡动脉上的经皮进入部位通向例如在肾动脉内的目标治疗部位。
调制装置400可进一步包括具有近端416和远端418的可扩张笼状物414。在一些情况下，在扩张状态下，近端416可逐渐减小，而远端418相对于近端416可具有增大的截面面积。在一些实施方式中，可扩张笼状物414可由大体管状部件激光切割得到以形成期望的图案。虽然可扩张笼状物414示出为具有开放孔、大体支架似的结构，可以预期，笼状物414可形成具有许多不同构造中的任何一种。例如，在一些情况下，笼状物414可由许多大体纵向延伸的尖齿(tines)制成或者可由编织、编结、捆扎等一个或多个丝状体制成。这些仅是示例。
可以预期，按照要求，可扩张笼状物414可由许多不同的材料制成，诸如但不限于，金属、金属合金、形状记忆合金和/或聚合物，使得笼状物414能够在定位在体内时扩张形状。例如，可扩张笼状物414可由合金制成，诸如但不限于，镍钛诺或根据构造选择的材料，笼状物414可自扩张或者可能需要促动机构，如以下更详细地讨论的。在一些实施方式中，纤维可用来制作可扩张笼状物414，其可以是有芯纤维，例如，具有由镍钛诺制成的外壳并具有铂芯。还可以预期，可扩张笼状物414可由聚合物制成，包括但不限于，聚醚醚酮(PEEK)、尼龙、聚对苯二甲酸乙二醇酯(PET)、聚酰亚胺、聚醚嵌段酰胺等。
笼状物414的近端416可固定至或毗连细长外杆402的远端区域408。如上所述，在一些情况下，笼状物414可自扩张。可以预期，自扩张笼状物414在外力作用于笼状物414时可保持处于压缩(或者塌缩)状态。然后当外力释放时，笼状物414可扩张。在这种情况下，笼状物414可形成为扩张状态(如图2A所示)，然后压缩以适合装在递送鞘套412中。当到达目标位置时，递送鞘套412可缩回以展开可扩张笼状物414。
在其他实施方式中，***400可包括促动机构，例如，拉线432(见图7)，其可用来操控或促动可扩张笼状物414在塌缩和扩张形态之间转换。在一实施方式中，拉线432可附装至笼状物414的近端416，使得拉线432的推-拉促动可操控可扩张笼状物414，从而促动可扩张笼状物414在塌缩和扩张形态之间转换。在一些情况下，可向近侧拉动拉线432以拉动可扩张笼状物414，使可扩张笼状物414移至扩张形态。另外，可向远侧推动拉线432以使可扩张笼状物414移至塌缩形态。或者，可向远侧推动拉线432，这可允许可扩张笼状物414移至扩张状态。在这种情况下，可向近侧拉动拉线432，这可允许可扩张笼状物414移至塌缩状态。
图6B示出了包括了附加组件的图6A的调制***400。调制***400可进一步包括设置在可扩张笼状物414内表面上的内覆盖物或涂层422。在一些情况下，内覆盖物422可使用本领域通常已知的方法附接至笼状物414。内覆盖物422可由弹性体材料制成，诸如但不限于：聚氨酯、硅酮等。弹性体材料可帮助笼状物414在使用后闭合至未扩张的形态。然而，在一些情况下，诸如聚氨酯的弹性体可能由于消融产生的热而失效。为了防止弹性体失效，弹性体可用较高温度的材料(例如，用二氧化硅，掺杂到弹性体中以提高其熔点)隔离在电极周围，也可使用较高温度的尿烷(例如，浸渍涂覆而不是挤压的芳香烃)。或者，覆盖物材料可以是较低可伸展性的材料，例如，四氟乙烯(Tfe)、聚对苯二甲酸乙二醇酯(PET)、或纤维织物(例如，聚酯或聚合物涂覆的纤维织物)，其受消融温度的影响较小。可以预期，内覆盖物422可从笼状物414的近端416延伸至远端418。然而，这不是必需的。可以预期，内覆盖物422可延伸越过笼状物414期望的任何长度或部分长度，或者内覆盖物422甚至可以不存在。
调制***400可进一步包括一个或多个定位在可扩张笼状物414和/或内覆盖物422的外表面上用于传送射频能量至期望的治疗区域的电极组件424。可与本文公开的实施方式一起使用的示范性电极组件在名为“Spiral bipolar electrode renal denervationballoon”的美国专利申请序号第61/856,523号(代理案号1001.3432100)中公开，其全部内容通过引用合并在此。电极组件424在形式和功能上可类似于上述电极组件124a、124b。各电极组件424可构建为具有多层的柔性电路。绝缘的基层425可提供电极组件424的基座。基层425可由诸如聚酰亚胺的柔性聚合物构建而成，尽管可以考虑其他的材料。然而，本文公开的调制***并不旨在局限于仅使用柔性电路来传送治疗能量至治疗区域。可以预期，能量传送装置可以是期望的任何类型。由多个离散迹线组成的导电层可层叠在基层425的顶部。电极组件424可包括多个层叠在基层425顶部上的离散迹线428。这些迹线可包括用于电连接电极、组件和/或功率控制单元的接地迹线、有源电极迹线和传感器迹线(未明确示出)。接地电极迹线和有源电极迹线可包括多个电极426。可为各电极迹线设置三个电极426，然而，可使用更多或更少的电极。另外，一个或多个温度传感器427可设置在各电极组件424上。
可以预期，基于调制装置400的大小和/或期望的治疗区域，调制***400可包括任何期望数量的电极组件424。例如，调制***可包括一个、两个、三个、四个、五个或更多的电极组件。进一步可以预期，电极组件424可沿可扩张笼状物414的周长和/或长度错开，使得定位在调制装置上的电极组件424的数量可达到最大。
图6C示出包括附加组件的图6B中的调制***400。调制***400可进一步包括设置在可扩张笼状物414的外表面上和内覆盖物422(当其存在时)上的外覆盖物或涂层430。外覆盖物430可由弹性体材料制成，诸如但不限于：聚氨酯、硅铜等。弹性体材料可帮助笼状物414在使用后闭合至未扩张的形态。然而，在一些情况下，诸如聚氨酯的弹性体可能由于消融产生的热而失效。为了防止弹性体失效，弹性体可用较高温度的材料(例如，硅胶，掺杂到其中以提高熔点)隔离在电极周围，或者可使用较高温度的尿烷(例如，浸渍涂覆而不是挤压的芳香烃)。或者，覆盖物材料可以是较低可伸展性的材料，例如，四氟乙烯(Tfe)、聚对苯二甲酸乙二醇酯(PET)、或纤维织物(例如，聚酯或聚合物涂覆的纤维织物)，其受消融温度的影响较小。可以预期，外覆盖物430可从笼状物414的近端416延伸至远端418。然而，这不是必需的。可以预期，外覆盖物430可延伸越过笼状物414期望的任何长度或部分长度，或者外覆盖物430甚至可以不存在。根据需要，内和外覆盖物422、430可由相同材料制成，或者可由不同材料制成。在一些实施方式中，内和/或外覆盖物422、430中的一个或两者可省略。
在一些情况下，外覆盖物430可使用本领域通常已知的方法附接至内覆盖物422和/或笼状物414。同时，内和外覆盖物422、430可包住电极组件424和相关电子器件的全部或部分。可以预期，相对于将柔性电路固定至传统的可膨胀球囊，内和外覆盖物422、430可将电极组件424更稳固地固定至可扩张笼状物414，因为内和外覆盖物422、430夹住电极组件424，并且更能经受得住共价粘合结合。
在一些情况下，外覆盖物430可能不在电极组件42的电极426上延伸。例如，在施加外覆盖物430之前，电极426可涂覆或覆盖有掩模材料。一旦形成外覆盖物430，可去除掩模材料以露出电极426。在一些情况下，外覆盖物430可设置在电极426上，随后去除，诸如但不限于激光消融。这可允许电极426直接接触血管壁。在其他情况下，外覆盖物430可留在电极426上以允许绝缘的壁接触。进一步可以预期，外覆盖物430可从电极426上去除，于是电极426被独立地涂敷(例如使用聚对二甲苯)以绝缘接触期望的治疗区域。
图7示出图6A-6C的调制***，包括用以促动笼状物414在塌缩和扩张位置之间转换的示例性促动机构434。促动机构434可包括手柄或握持部分435和滑动机构436。滑动机构436可附接至拉线432的近端。如上面讨论的，拉线432的远端可附装至或毗连笼状物的近端416。促动机构434可配置成使滑动机构436的促动导致拉线432向近侧和/或向远侧促动，随后，促动笼状物414扩张或收缩。虽然促动机构434示出为包括手柄435和滑动机构436，可以预期，拉线432能够以期望的任何方式促动，诸如但不限于，触发器、按钮等。例如，促动机构434在形式和功能上可类似于上述促动机构134。
图8示出另一个示例性肾神经调制装置500的远侧部分，其具有覆盖有涂层的笼状结构。肾神经调制***500可包括具有近端和远端区域508的细长外杆502。细长外杆502可从远端区域508向近侧延伸至配置成留在患者体外的近端。调制装置500可进一步包括细长内杆504，其具有可滑动地设置在细长外杆502的腔506内的防止损伤的末端520。细长内杆504可从远端区域510向近侧延伸至配置成留在患者体外的近端。细长内杆504可包括腔(未明确示出)，其可滑动地容纳导丝在其中。在一些情况下，在没有导丝腔时，调制装置500可具有固定的丝线远端。尽管未示出，细长内和/或外杆504、502的近端可包括附装其上用于连接其他治疗装置或者提供端口以便利其他治疗的毂。可以预期，细长内和/或外杆504、502的刚度可改变以形成用于各种血管直径和血管树内各种位置的调制装置500。细长内和/或外杆504、502在形式和功能上可类似于上述细长内和/或外杆104、404、102、402。
调制装置500可进一步包括具有近端516和远端518的可扩张笼状物514。在一些情况下，在扩张状态下，近端516可逐渐减小，而远端518相对于近端516可具有增大的截面面积。在一些实施方式中，可扩张笼状物514可由大体管状部件激光切割得到以构成期望的图案。虽然未明确示出，可扩张笼状物可具有开放孔、大体支架似的结构。在其他情况下，可以预期，笼状物514可形成具有许多不同构造中的任何一种。例如，在一些情况下，笼状物514可由许多大体纵向延伸的尖齿(tines)制成或者可由编织、编结、捆扎等一个或多个丝状体制成。这些仅是示例。笼状物514在形式和功能上可类似于上述笼状物414。取决于构建选择的材料，笼状物514可自扩张或者可能需要诸如上述促动机构134、434的促动机构。
笼状物514的近端516可固定至或毗连细长外杆502的远端区域508。如上所述，在一些情况下，笼状物514可自扩张。可以预期，自扩张的笼状物514在外力作用于笼状物514时可保持处于压缩(或者塌缩)状态。然后当外力释放时，笼状物514可扩张。在这种情况下，笼状物514可形成处于扩张状态(如图8所示)，然后压缩以适合装在递送鞘套512中。到达目标位置时，递送鞘套512可缩回以展开可扩张笼状物514。
在其他实施方式中，***500可包括促动机构，诸如上述促动机构134、434，其可用来操控或促动可扩张笼状物514在塌缩和扩张形态之间转换。在一实施方式中，拉线可附装至笼状物514的近端516，使得拉线的推-拉促动可操控可扩张笼状物514，从而促动可扩张笼状物514在塌缩和扩张形态之间转换。在一些情况下，可向近侧拉动拉线以拉动可扩张笼状物514，使可扩张笼状物514移至扩张形态。另外，可向远侧推动拉线以使可扩张笼状物514移至塌缩形态。或者，可向远侧推动拉线，这可允许可扩张笼状物514移至扩张状态。在这种情况下，可向近侧拉动拉线，这可允许可扩张笼状物514移至塌缩状态。
调制***500可进一步包括设置在可扩张笼状物514的内表面上的内覆盖物或涂层(未明确示出)。可以预期，内覆盖物可延伸越过笼状物514期望的任何长度或部分长度，或者内覆盖物甚至可以不存在。然而，这不是必需的。可以预期，在一些情况下，内覆盖物可从笼状物514的近端516延伸至远端518。
调制***500可进一步包括一个或多个定位在可扩张笼状物514和/或内覆盖物的外表面上用于传送射频能量至期望的治疗区域的电极组件(未明确示出)。电极组件在形式和功能上可类似于上述电极组件124a、124b。然而，本文公开的调制***并不旨在局限于仅使用柔性电路来传送治疗能量至治疗区域。可以预期，能量传送装置可以是期望的任何类型。电极组件上的电极526通过一个或多个电导线528可相互连接，连结至其他的电子元件，和/或功率控制单元。根据需要，电极526可以以双极或单极模式操作。
可以预期，基于调制装置500的大小和/或期望的治疗区域，调制***500可包括任何期望数量的电极组件。例如，调制***可包括一个、两个、三个、四个、五个、或更多的电极组件。进一步可以预期，电极组件可沿可扩张笼状物514的周长和/或长度错开，使得定位在调制装置上的电极组件的数量可达到最大。
调制***500可进一步包括设置在可扩张笼状物514的外表面上和内覆盖物(当存在时)上方的外覆盖物或涂层530。外覆盖物530在形式和功能上可类似于上述外覆盖物130、430。可以预期，外覆盖物530可具有近端531和远端533。在一些情况下，覆盖物530的近端531可定位在笼状物514近端516的远侧。进一步可以预期，覆盖物530的远端533可定位在笼状物514远端518的近侧或可延伸至笼状物514的远端518。这可允许血液在治疗过程中向调制***500的下游灌注。然而，可以预期，根据需要，外覆盖物530的近端531或远端533中的一个或两者可延伸至框架514的近端516或远端518。可以预期，内覆盖物可具有与外覆盖物530相似的构造。根据需要，内和外覆盖物530可由相同材料制成，或者可由不同材料制成。在一些实施方式中，内和/或外覆盖物530中的一个或两者可省略。
在一些情况下，外覆盖物530可使用本领域通常已知的方法附接至内覆盖物和/或笼状物514。同时，内和外覆盖物530可包住电极组件和相关电子器件的全部或部分。可以预期，相对于将柔性电路固定至传统的可膨胀球囊，内和外覆盖物530可将电极组件更稳固地固定至可扩张笼状物514，因为内和外覆盖物530夹住电极组件，并且更能经受得住共价粘合结合。在一些情况下，外覆盖物530可能不在电极组件的电极526上延伸。例如，在应用外覆盖物530之前，电极526可涂覆或覆盖有掩模材料。一旦外覆盖物530形成，可去除掩模材料以露出电极530。在一些情况下，外覆盖物530可设置在电极530上，随后去除，诸如但不限于激光消融。这可允许电极526直接接触血管壁。在其他情况下，外覆盖物530可留在电极526上以允许绝缘的壁接触。进一步可以预期，外覆盖物530可从电极526上去除，于是电极526被独立地涂覆(例如使用聚对二甲苯)以绝缘地接触期望的治疗区域。
可用于调制***100、300、400、500(和/或本文公开的其他装置)的各种组件的材料可包括那些通常与医疗器械相关的材料。为简明起见，以下讨论参照调制***100、300、400、500。然而，这并不止在限制本文公开的装置和方法，因为讨论可适用于其他类似的管状部件和/或可扩张部件和/或本文公开的管状部件和/或可扩张部件的组件。
调制***100、300、400、500及其各种组件可由金属，金属合金，聚合物(下文公开了其一些示例)，金属-聚合物复合物，陶瓷，及其组合等，或者其他合适的材料。合适的聚合物的一些示例可包括聚四氟乙烯(PTFE)，乙烯-四氟乙烯(ETFE)，氟化乙烯丙烯(FEP)，聚甲烯(POM，例如，杜邦公司出售的)，聚醚嵌段酯，聚氨酯(例如，聚氨酯85A)，聚丙烯(PP)，聚氯乙烯(PVC)，聚醚酯(例如，DSM工程塑料公司出售的)，醚基或酯基共聚物(例如，丁基/聚(亚烃基醚)邻苯二甲酸酯和/或诸如杜邦公司出售的的聚酯弹性体)，聚酰胺(例如，拜尔公司出售的或埃尔夫阿托公司出售的)，弹性体聚酰胺，嵌段聚酰胺/醚，聚醚嵌段酰胺(PEBA，例如以为商标名出售的产品)，乙烯-乙酸乙烯酯共聚物(EVA)，硅树脂，聚乙烯(PE)，高马勒克斯高密度聚乙烯，高马勒克斯低密度聚乙烯，线性低密度聚乙烯(例如，)，聚酯，聚对苯二酸丁烯酯(PBT)，聚对苯二酸乙烯酯(PET)，聚对苯二酸三甲烯酯，聚萘二甲酸乙烯酯(PEN)，聚醚醚酮(PEEK)，聚酰亚胺(PI)，聚醚酰亚胺(PEI)，聚苯硫醚(PPS)，聚苯醚(PPO)，聚对苯二酰对苯二胺(例如，)，聚砜，尼龙，尼龙-12(诸如EMS AmericanGrilon公司出售的)，全氟(乙烯基丙醚)(PFA)，乙烯基乙烯醇，聚烯烃，聚苯乙烯，环氧树脂，聚偏氯乙烯(PVdC)，聚(苯乙烯-b-异丁烯-b-苯乙烯)(例如，SIBS及/或SIBS 50A)，聚碳酸脂，离聚物，生物相容聚合物，其他合适材料，或者前述材料的混合物，组合物，共聚物，聚合物/金属组合物，等等。在一些实施方式中，鞘套可与液晶聚合物(LCP)混合。例如，混合物可包含高达大约6％的LCP。
合适的金属和金属合金的一些示例包括诸如304V，304L，和316LV不锈钢的不锈钢；软钢；诸如线弹性和/或超弹性镍诺钛的镍-钛合金；诸如镍-铬-钼合金(例如，诸如625的UNS:N06625，诸如 的UNS:N06022，诸如的UNS:N10276，其他合金等)的其他镍合金，镍-铜合金(例如，诸如400，400，400等的UNS:N04400)，镍-钴-铬-钼合金(例如，诸如等的UNS:R30035)，镍-钼合金(例如，诸如ALLOY的UNS:N10665)，其他镍-铬合金，其他镍-钼合金，其他镍-钴合金，其他镍-铁合金，其他镍-铜合金，其他镍-钨合金或钨合金等；钴-铬合金；钴-铬-钼合金(例如，诸如等的UNS:R30003)；铂富集不锈钢；钛；及其组合等；或者任何其他合适的材料。
如本文提到的，在市售镍-钛或镍诺钛合金的家族里，有称作“线弹性”或“非超弹性”的种类，尽管其在化学性质方面类似于常见的形状记忆和超弹性种类，但其可呈现出独特且有益的机械性能。线弹性和/或非超弹性镍诺钛与超弹性镍诺钛的区别可在于，线弹性和/或非超弹性镍诺钛在应力/应变曲线中不具有实质的“超弹性坪”(“superelasticplateau”)或“疲劳区域”(“flag region”)，而超弹性镍诺钛则具有。相反，在线弹性和/或非超弹性镍诺钛中，随着可恢复应变增大，应力以大致线性，或稍微线性，但不必完全线性的关系持续增大直至塑性变形开始或者至少以比超弹性镍诺钛所示的超弹性坪和/或标记区域更为线性的关系。这样，为了本公开的目的，线弹性和/或非超弹性镍诺钛也可称为“大致”线弹性和/或非超弹性镍诺钛。
在一些情况下，线弹性和/或非超弹性镍诺钛与超弹性镍诺钛的区别也可在于，线弹性和/或非超弹性镍诺钛可在保持大致弹性的同时承受多达大约2-5％的应变(例如，在塑性变形之前)，而超弹性镍诺钛在塑性变形之前可承受多达大约8％的应变。这两种材料都能够与诸如不锈钢的其他线弹性材料(其也能够根据组分而区别开)区别开，其他线弹性材料在塑性变形之前仅可承受大约0.2到0.44％的应变。
在一些实施方式中，线弹性和/或非超弹性镍-钛合金是不具有任何马氏体相变/奥氏体相变的合金，相变可通过差示扫描量热仪(DSC)和动态金属热分析(DMTA)在很大的温度范围内进行分析而检测得到。例如，在一些实施方式中，在大约-60摄氏度(℃)到大约120℃的范围内通过差示扫描量热仪(DSC)和动态金属热分析(DMTA)未测得线弹性和/或非超弹性镍-钛合金的马氏体相变/奥氏体相变。因此，在这个非常宽广的温度范围内，这种材料的机械弯曲性能通常不会受到温度的影响。在一些实施方式中，线弹性和/或非超弹性镍-钛合金在环境温度或室温下的机械弯曲性能与在体温下的机械性能基本相同，例如，都不显示超弹性坪和/或标记区域。换句话说，在宽广的温度范围内，线弹性和/或非超弹性镍-钛合金保持其线弹性和/或非超弹性特性和/或性能。
在一些实施方式中，线弹性和/或非超弹性镍-钛合金中镍的重量百分比可在大约50到大约60的范围内，其余部分基本为钛。在一些实施方式中，镍的重量百分比在大约54到大约57的范围内。合适的镍-钛合金的一个示例是日本神奈川县的Furukawa TechnoMaterial Co.销售的FHP-NT合金。在美国专利第5,238,004号和6,508,803号中公开了镍钛合金的一些示例，通过引用将其合并在此。其他合适的材料可包括ULTANIUMTM(可从Neo-Metrics公司购买)和GUM METALTM(可从丰田公司购买)。在一些其他的实施方式中，超弹性合金(例如超弹性镍诺钛)能够用来实现期望的性能。
在至少一些实施方式中，调制***100、300、400、500的部分也可掺杂有，材料为，或包括不透射线的材料。不透射线的材料理解为能够在医疗过程中在荧光透视屏或其他成像技术上生成相对较亮图像的材料。这个相对较亮的图像可帮助调制***100、300、400、500的使用者判定其位置。不透射线的材料的一些示例能够包括但不限于，金，铂，钯，钽，钨合金，装有不透射线的填料的聚合物材料等。此外，其他不透射线的标记带和/或线圈也可包括在调制***100、300、400、500的设计中以实现相同的结果。
在一些实施方式中，给予调制***100、300、400、500一定程度的磁共振成像(MRI)兼容性。例如，调制***100、300、400、500的部分可由基本不使图像失真及生成实质伪影(即，图像中的间隙)的材料制成。例如，某些铁磁材料可能不适合，因为它们会在MRI图像中生成伪影。管状轴102或其部分也可由MRI机器能够成像的材料制成。显示出这些特性的一些材料包括，例如钨，钴-铬-钼合金(例如，诸如等的UNS:R30003)，镍-钴-铬-钼合金(例如，诸如等的UNS:R30035)，镍诺钛等，以及其他材料。
应当认识到，本公开在许多方面仅是示例性的。变化可体现在细节，特别是形状、尺寸和步骤的设置等方面，而不会超出本发明的范围。这可包括，在适当的程度，使用用于其他实施方式中一个示范实施方式的任何特征。当然，本发明的范围由所附的权利要求表示。
Claims (15)
1.一种血管内神经调制***，包括：
具有近端、远端和在所述近端和远端之间延伸的腔的细长外杆；
具有近端和远端的细长内杆；
具有近端和远端的可扩张笼状物，所述可扩张笼状物的所述近端附接至所述细长外杆的所述远端附近；
附接至所述可扩张笼状物附近的电极组件，所述电极组件包括具有一个或多个电极的柔性电路；
设置在所述可扩张笼状物的内表面上的内覆盖物；和
设置在所述可扩张笼状物的外表面上与所述内覆盖物不同的外覆盖物；
其中所述柔性电路设置在所述内覆盖物和所述外覆盖物之间；并且
其中所述***不包括膨胀腔。
2.根据权利要求1所述的神经调制***，其中所述电极组件附接至所述内覆盖物的表面。
3.根据权利要求1至2中任一所述的神经调制***，其中所述电极组件附接至所述可扩张笼状物的外表面。
4.根据权利要求1所述的神经调制***，其中所述电极组件附接至所述外覆盖物的内表面。
5.根据权利要求1所述的神经调制***，其中所述外覆盖物仅沿所述可扩张笼状物的长度的部分延伸。
6.根据权利要求1所述的神经调制***，其中所述外覆盖物从所述可扩张笼状物的所述近端延伸至所述可扩张笼状物的所述远端。
7.根据权利要求1所述的神经调制***，进一步包括一个或多个附加的电极组件。
8.根据权利要求7所述的神经调制***，其中所述电极组件和所述一个或多个附加的电极组件沿所述可扩张笼状物的周长隔开。
9.根据权利要求1所述的神经调制***，其中所述外覆盖物包含弹性体材料，且所述内覆盖物包含弹性体材料。
10.根据权利要求9所述的神经调制***，其中所述外覆盖物和所述内覆盖物包含相同的弹性体材料。
11.根据权利要求9所述的神经调制***，其中所述外覆盖物和所述内覆盖物包含不同的弹性体材料。
12.根据权利要求1所述的神经调制***，其中所述外覆盖物在所述电极组件的电极上延伸，且所述电极配置为绝缘接触周围的治疗区域。
13.根据权利要求1所述的神经调制***，其中所述外覆盖物没有在所述电极组件的电极上延伸。
14.根据权利要求1所述的神经调制***，其中在所述可扩张笼状物的所述近端和所述远端位置，所述内覆盖物和所述外覆盖物中设置有多个孔，从而允许血液当所述可扩张笼状物在血管内处于扩张状态时向所述神经调制***的下游灌注。
15.根据权利要求1所述的神经调制***，其中所述可扩张笼状物包括多个开放孔，其中所述内覆盖物覆盖所述多个开放孔，并且其中所述外覆盖物覆盖所述多个开放孔。
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| CN109310863A (zh) | 2016-03-09 | 2019-02-05 | 卡迪诺米克公司 | 心脏收缩性神经刺激***和方法 |
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| US10524859B2 (en) | 2016-06-07 | 2020-01-07 | Metavention, Inc. | Therapeutic tissue modulation devices and methods |
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| US20150018818A1 (en) | 2015-01-15 |
| US11266463B2 (en) | 2022-03-08 |
| EP3019105A1 (en) | 2016-05-18 |
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| EP3019105B1 (en) | 2017-09-13 |
| WO2015006480A1 (en) | 2015-01-15 |
| CN105377169A (zh) | 2016-03-02 |
| US20200261151A1 (en) | 2020-08-20 |
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